Bristol Immune Drug Success May Spur Industry Race; Synta Announces Ganetespib Presentations for Clinical Oncology Print E-mail
By Staff and Wire Reports   
Monday, 04 June 2012 19:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 4, 2012.

The early success of an experimental drug from Bristol-Myers Squibb Co. (NYSE:BMY) that’s designed to unleash the body’s immune-system defenses against cancer sets the stage for an industry wide race to produce similar treatments.

The drug shrank tumors in people with advanced lung, kidney and skin cancer in 18 percent to 28 percent of patients, depending on the illness, who had failed on other therapies, according to data from a 296-patient trial reported June 2 at the American Society of Clinical Oncology meeting in Chicago.

The findings hint that therapies like the Bristol drug, that prompt killer T-cells to eliminate invaders, may work against many tumors, said James Allison, an immunologist at Memorial Sloan-Kettering Cancer Center in New York.

“There is no reason to think that all cancers might not be susceptible to immune therapy,” Allison said by telephone, noting that the human immune system can wipe out whole organs when it rejects a transplant.

Drugmakers and scientists have been trying to find ways to boost the immune system against cancer for decades, with little successes until recently.

In 2010, Dendreon Corp.'s (NASDAQ:DNDN) Provenge, a prostate cancer treatment, was approved in the U.S. as the first therapy designed to train the body’s immune system to attack tumor cells as if they were a virus. Last year, Bristol-Myers immune boosting antibody Yervoy was approved for advanced melanoma.

Now “the whole idea of immunotherapy is really blossoming,” said David Chang, a vice president for Amgen Inc., which is testing immune-boosting treatments for melanoma and leukemia, in an interview at the oncology conference. “It is going to be the next wave in cancer treatments.”



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Synta Pharmaceuticals Corp. (NASDAQ:SNTA)
announced results from studies evaluating the Companys lead drug candidate, ganetespib, a potent second-generation Hsp90 inhibitor, presented at the annual meeting of the American Society for Clinical Oncology (ASCO).

We believe results presented at the ASCO conference this year further validate the high clinical potential of ganetespib for the treatment of oncologic indications, said Vojo Vukovic, Chief Medical Officer of Synta. In contrast with ganetespib or 17-AAG, a number of other Hsp90 inhibitors have shown a high incidence of ocular toxicity in patients. Results presented today from preclinical experiments show that physicochemical properties associated with penetration and accumulation in retina correlate with observed clinical ocular toxicity seen with other Hsp90 inhibitors.

In addition to results supporting the observed favorable clinical safety profile for ganetespib, other findings presented today establish exciting potential for Hsp90 inhibition in ALK+, ROS1+, and RET+ lung cancer, continued Dr. Vukovic. These results support our parallel development approach for ganetespib entailing both monotherapy and combination treatment evaluation across multiple cancer indications. Results from our Phase 1 combination study of ganetespib and docetaxel, updated today, were used to inform the choice of dose and schedule in our ongoing Phase 2b/3 GALAXY study in second-line non-small cell lung cancer.




Also Monday:





AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX)
, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, announced today that it completed its previously announced private placement of common stock and warrants to purchase common stock on June 1, 2012.

AcelRx Pharmaceuticals, Inc. ("AcelRx") (Nasdaq: ACRX)
, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, announced today that Richard King, President and Chief Executive Officer of AcelRx, will present at the Jefferies 2012 Global Healthcare Conference in New York.

Active Biotech (NASDAQ OMX NORDIC: ACTI)
and Ipsen (Euronext: IPN; ADR: IPSEY) today presented overall survival (OS) data from the tasquinimod Phase II study in chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC) at the scientific conference “2012 ASCO Annual Meeting” held in Chicago (USA).

Aetna (NYSE: AET)
announced today a multi-year pharmacy benefit management agreement with Assurant Health, a leading provider of major medical, supplemental and fixed-benefit health plans for individuals, families and small employers.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that Johanna Bendell, MD, Director of Gastrointestinal Cancer Research and Associate Director of Drug Development at the Sarah Cannon Research Institute in Nashville, Tennessee, presented Phase 3 results for perifosine in refractory colorectal cancer yesterday, at the American Society of Clinical Oncology (ASCO) Annual Meeting which is being held in Chicago.

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. (Nasdaq: SGEN) today announced interim data from a phase I clinical trial evaluating ASG-5ME for the treatment of castration-resistant prostate cancer (CRPC).

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced results today from its Phase I extension study with ALN-VSP, a systemically delivered RNAi therapeutic for the treatment of advanced solid tumors with liver involvement.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced updated clinical data from the pivotal PACE trial of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) or Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL), who are resistant or intolerant to dasatinib or nilotinib or who have the T315I mutation.

Baxter International Inc. (NYSE:BAX)
today announced that it has entered into an exclusive global agreement with Chatham Therapeutics, LLC, an affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), for the development and commercialization of potential treatments for hemophilia B utilizing Chatham’s gene therapy technology.

Bio-Path Holdings, Inc. (OTCQX: BPTH)
(“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that its common stock began trading on the quality-controlled OTCQX on Friday, June 1, 2012.

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the Jefferies 2012 Global Healthcare Conference in New York on June 6, 2012 at 11:00 am EDT.

Brain Resource, Inc., (BRRZY: OTC US, BRC: ASX)
, developer of innovative cognitive assessments and exercises to improve brain health, is scheduled to present at the upcoming SharpBrains Virtual Summit from June 7- 14.

Celsion Corporation (NASDAQ: CLSN)
, a leading oncology drug development company, today announced that it has made available its second in a series of "Meet the Investigators" webcast interviews, featuring Ronnie T.P. Poon, MD (QMH), MS, PhD, FRCS (Edin), FACS, Professor of Surgery at the University of Hong Kong, and a Lead Asia Pacific Principal Investigator in Celsion's pivotal Phase III HEAT Study of ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of primary liver cancer.

Codexis, Inc. (NASDAQ:CDXS)
, a developer of industrial enzymes to enable the cost-advantaged production of biofuels, bio-based chemicals and pharmaceutical intermediates, today announced the appointment of John J. Nicols as President and Chief Executive Officer.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical company specializing in oncology, will hold a conference call to discuss favorable clinical results from the Phase 1b/2 clinical trial with INNO-206 in patients with advanced soft tissue sarcoma and next steps for the INNO-206 program in this indication.

DATATRAK International, Inc. (OTCQX: DATA)
, a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced Ethos Clinical Group joined DATATRAK's Connect Partner Program™. Ethos is a Contract Research Organization (CRO) with a focus on conducting clinical research in special populations, such as women and minorities.

Digirad Corporation (NASDAQ: DRAD)
today announced that the deadline for stockholders to timely submit to Digirad proposals to be brought before Digirad's 2012 Annual Meeting of Stockholders pursuant to Rule 14a-8 promulgated under the Securities Exchange Act of 1934, as amended, is June 12, 2012.

Eli Lilly and Company (NYSE: LLY)
announced results of a Phase II trial evaluating ALIMTA® (pemetrexed for injection) in combination with a platinum chemotherapy and radiation for patients with locally advanced non-small cell lung cancer (NSCLC).

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that it has reached an agreement with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, to conduct a non-interference study to be used to support a Post-Exposure Prophylaxis (PEP) indication for BioThrax® (Anthrax Vaccine Adsorbed).

Exelixis, Inc. (NASDAQ:EXEL)
today reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Magellan™ Robotic System, including the catheter and accessories.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK)
announced today the signing of a definitive agreement under which Hi-Tech acquired exclusive rights to the Cormax® brand from Watson Laboratories for an undisclosed sum of money.

Human Genome Sciences, Inc. (NASDAQ: HGSI)
announced today that its presentation at the Goldman Sachs 33rd Annual Global Healthcare Conference will be webcast and may be accessed at www.hgsi.com.

Impax Laboratories, Inc. (NASDAQ:IPXL)
today announced that the Company will present at the Goldman Sachs 33rd Annual Global Healthcare Conference on Thursday, June 7, at 10:00 a.m. PT.

Incyte Corporation (Nasdaq: INCY)
presented preliminary results today from the ongoing Phase I clinical trial for its oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB024360, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Integrated Management Information, Inc. (IMI Global) (OTCBB: INMG)
, a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, recount the Memorial Day weekend events showcasing Heinen's Own Beef and the Where Food Comes From program with beef producers in-store as a huge success.

Laboratory Corporation of America® Holdings (NYSE: LH)
and MEDTOX Scientific, Inc. (NASDAQ: MTOX), a provider of high quality specialized laboratory testing services and on-site/point-of-collection testing (POCT) devices, today announced that they had entered into a definitive merger agreement under which LabCorp would acquire MEDTOX for a purchase price of $27.00 per share in cash, representing a total enterprise value of approximately $241,000,000.

Medistem Inc. (PINKSHEETS: MEDS)
announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial.

The following blog from Bob Lorsch, CEO of MMRGlobal, Inc. (OTCBB: MMRF), was picked up today and can be viewed at http://blog.mmrglobal.com:  A little over a year ago, I couldn't even spell "Hockey."

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the abstract reviewing a meta-analysis of Phase 3 clinical trial for Intraoperative lymphatic mapping (ILM) of lymph nodes in breast cancer, compared to standard of care techniques has been published in conjunction with the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO).

Oramed Pharmaceuticals (OTCBB: ORMP.OB)
, a developer of oral delivery systems, announced today that its abstract, "Concomitant oral insulin and exenatide therapies significantly curb postprandial glucose in pigs," which reports on the impact of its oral insulin capsule (ORMD-0801) delivered in combination with its oral exenatide capsule (ORMD-0901), has been accepted for presentation at the 72nd Scientific Sessions of the American Diabetes Association (ADA).

PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI)
today announced that John P. McLaughlin, the company's president and chief executive officer, is scheduled to present at the Jefferies 2012 Global Healthcare Conference on Wednesday, June 6, 2012, at 4:00 p.m. ET in New York City.

PerkinElmer, Inc., (NYSE:PKI)
a global leader focused on improving the health and safety of people and the environment, announced today that on Thursday, June 7, 2012, Kevin Hrusovsky, President, Life Sciences and Technology, PerkinElmer, will present a keynote speech at the Company’s Revolutionaries for Global Health Summit.

Pharmacyclics, Inc (Nasdaq: PCYC)
announced today updated results from three trials of Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib (PCI-32765), for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Senesco Technologies, Inc. (NYSE MKT: SNT)
reported today on the progress of its Phase 1b/2a study for the treatment of multiple myeloma, which is the subject of a poster presented today at the 2012 Annual Meeting of the American Society of Clinical Oncology.

ShangPharma Corporation (NYSE: SHP)
("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today celebrated the 10th anniversary of its partnership with Eli Lilly and Company ("Lilly").

Simulations Plus, Inc. (NASDAQ: SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported preliminary revenues for its third quarter of fiscal year 2012 ended May 31, 2012 (3QFY12).

Synta Pharmaceuticals Corp. (NASDAQ: SNTA)
today announced results from studies evaluating the Company’s lead drug candidate, ganetespib, a potent second-generation Hsp90 inhibitor, presented at the annual meeting of the American Society for Clinical Oncology (ASCO).

Targacept Inc. (NASDAQ: TRGT)
today announced management changes that include the formation of an Office of the Chairman led by Mark Skaletsky, Chairman of Targacept’s Board of Directors.

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA)
, a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced that the Company will present five posters during the scientific session at SLEEP 2012 on Monday, June 11.

ViroPharma Incorporated (NASDAQ: VPHM)
today announced the initiation of a Phase 2 program to evaluate maribavir for the treatment of cytomegalovirus infections in transplant recipients.

WuXi PharmaTech (NYSE: WX)
, a leading pharmaceutical, biotechnology and medical device R&D services company with operations in China and the United States, today commented on the conviction of  a former employee for the theft of chemical compounds.

XenoPort, Inc. (Nasdaq:XNPT) announced today that it has promoted Vincent J. Angotti to the newly created role of Executive Vice President, Chief Operating Officer, with responsibilities for commercialization, legal, human resources, information technology, facilities, finance and investor relations.

XTL Biopharmaceuticals Ltd. (TASE: XTL) (OTC: XTLBY) (the "Company"), a biopharmaceutical development company, announced today that it has filed an application for relisting its ADRs on the NASDAQ Stock Exchange.



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